Dataset Information

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial.

ABSTRACT:

Background

Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequately powered randomized controlled trial.

Methods

We plan to include one hundred patients undergoing elective coronary artery bypass graft with cardiopulmonary bypass who will be randomized to receive either volatile anesthetics during cardiopulmonary bypass or total intravenous anesthesia. The primary endpoint of the study is to assess the inflammatory response during cardiopulmonary bypass by measuring PMN-elastase serum levels. Secondary endpoints include serum levels of other pro-inflammatory markers (IL-1?, IL-6, IL-8, TNF?), anti-inflammatory cytokines (TGF? and IL-10), and microRNA expression in peripheral blood to achieve possible epigenetic mechanisms in this process. In addition clinical endpoints such as presence of major complications in the postoperative period and length of hospital and intensive care unit stay will be assessed.

Discussion

The trial may determine whether adding volatile anesthetic during cardiopulmonary bypass will attenuate the inflammatory response.

Trial registration

ClinicalTrials.gov NCT02672345 . Registered on February 2016 and updated on June 2020.

SUBMITTER: Cardoso TAAM

PROVIDER: S-EPMC7789561 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial.

Cardoso Thiago Augusto Azevedo Maranhão TAAM Kunst Gudrun G Neto Caetano Nigro CN de Ribamar Costa Júnior José J Silva Carlos Gustavo Santos CGS Bastos Gisele Medeiros GM Borges Jéssica Bassani JB Hirata Mario Hiroyuki MH

Trials 20210106 1

<h4>Background</h4>Recent experimental evidence shows that sevoflurane can reduce the inflammatory response during cardiac surgery with cardiopulmonary bypass. However, this observation so far has not been assessed in an adequately powered randomized controlled trial.<h4>Methods</h4>We plan to include one hundred patients undergoing elective coronary artery bypass graft with cardiopulmonary bypass who will be randomized to receive either volatile anesthetics during cardiopulmonary bypass or tota ...[more]

PMID: 33407763

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Project description:BACKGROUND:Intralipid is a necessary fatty acid carrier that has been safely used as an energy supplier in the clinic. It has played an important role in rescuing the cardiac arrest caused by local anesthetic toxicity. In recent years, experimental studies have shown that intralipid postconditioning (ILPC) could reduce myocardial ischemic/reperfusion (I/R) injuries. Our research group has innovatively conducted a pilot randomized controlled trial (RCT), and the results showed that ILPC could reduce the release of cTnT and CK-MB, biomarkers of myocardial I/R injury, in valve replacement surgery. However, the potential effects of ILPC on the clinical outcome of adult cardiac surgery patients are unclear. Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB) trial is aimed to further study whether ILPC could improve short-term and long-term clinical outcome, as well as cardiac function in adult cardiac surgery patients. METHODS:The iCPB trial is an ongoing, single-center, prospective, double-blinded, large sample RCT. In total, 1000 adults undergoing cardiac surgery will be randomly allocated to either the ILPC group or the control group. The intervention group received an intravenous infusion of 2?mL/kg of 20% intralipid (medium-chain and long-chain fat emulsion injection C6~C24, Pharmaceutical) within 10?min before aortic cross-unclamping, and the control group received an equivalent volume of normal saline. The primary endpoints are complex morbidity of major complications during hospitalization and all-cause mortality within 30?days after surgery. The secondary endpoints include (1) all-cause mortality 6?months and 1?year postoperatively; (2) the quality of life within 1?year after surgery, using the QoR-15 questionnaire; (3) the postoperative cardiac function evaluated by LVEF, LVEDS, and LVEDD, and the myocardial injury evaluated by CK-MB, cTnT, and BNP; and (4) short-term clinical outcomes during hospitalization and total cost are also detailed evaluated. DISCUSSION:The iCPB trial is the first to explore ILPC on the clinical outcome of adult cardiac surgery patients. The results are expected to provide potential evidences about whether ILPC could reduce the morbidity and mortality and improve the cardiac function and quality of life. Therefore, the results will provide a rationale for the evaluation of the potentially clinically relevant benefit of intralipid therapy. TRIAL REGISTRATION:Chictr.org.cn ChiCTR1900024387. Prospectively registered on 9 July 2019.

Project description:BackgroundPreventing myocardial ischemia-reperfusion injury in on-pump cardiac surgeries remains an enormous challenge. Sevoflurane postconditioning has been effective at overcoming this challenge by modulating inflammatory mediators and ameliorating antioxidative stress. Dexmedetomidine (DEX) is a commonly used medication for cardiac patients with organ-protective properties that lead to positive outcomes. Whether DEX also has cardiac-protective properties and the associated mechanism in sevoflurane postconditioning-based valve replacement surgeries are unknown.ObjectiveThis study was conducted to observe the effect of DEX administration before cardiopulmonary bypass (CPB) on myocardial injury, oxidative stress, and inflammatory response indicators in the peripheral blood.MethodsTwenty-eight eligible cardiac patients who underwent valve replacement surgery with standard sevoflurane postconditioning were included in the study. The patients were randomly divided into a DEX group and a non-DEX group according to whether DEX (0.5-µg/kg overload dose for 10 minutes and a 0.5-μg/kg/h maintenance dose) or saline was administered from induction to the beginning of CPB. The primary outcome was the cardiac troponin I concentration (cTnI) in the blood 24 hours after CPB. The levels of malondialdehyde (MDA), superoxide dismutase, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-8 (IL-8) were also measured.ResultsThe mean cTnI at 24 hours after CPB was clearly decreased in the DEX group compared with that in the non-DEX group (4.16 ± 1.58 vs. 6.90 ± 3.73, P < 0.05). TNF-α levels were lower in the DEX group after CPB (T1-T5), with a significant difference found at 1-6 hours after CPB (1 hour, 19.03 vs. 28.09; 6 hours, 20.74 vs. 30.94, P < 0.05). The IL-6 and IL-8 concentrations in the DEX group were dramatically increased at 6 hours after CPB (P < 0.05). The MDA content and superoxide dismutase activity were comparable between the 2 groups. A lower proportion of anemia cases were noted after CPB in the DEX group than in the non-DEX group (non-DEX, 10% vs. DEX, 5%, P < 0.05).ConclusionsIn valve replacement surgery with sevoflurane postconditioning, pre-CPB administration of DEX can reduce the cTnI level at 24 hours after CPB and brings synergic benefits of the inflammatory response.

Project description:BACKGROUND:There is no consensus on the ventilation management during cardiopulmonary bypass (CPB), and the anesthesiologists or the surgeons usually ventilate the lungs with different ventilation strategies or keep them static. Better outcomes are more likely to occur when the ventilation is administered during CPB according to the existing literatures. However, the use of high fraction of inspired oxygen (FiO2) is debatable in cardiac surgery. And the potential effects of strategies combining low tidal volume (VT) ventilation with different FiO2 during CPB on postoperative pulmonary complications (PPCs) are unclear. DESIGN:The VONTCPB trial is a single-center, prospective, double-blinded, randomized, controlled trial. We are going to recruit total 420 elective cardiac surgery patients with median sternotomy under CPB, who will be equally randomized into three different ventilation strategy groups: NoV, LOV and HOV. (1) The NoV group receives no mechanical ventilation during CPB; (2) the LOV group receives a low VT of 3-4?ml/kg of ideal body weight (IBW) with the respiratory rate (RR) of 10-12 acts/min, and the positive end-expiratory pressure (PEEP) of 5-8 cmH2O during CPB; the FiO2 is 30%; (3) the HOV group receives a low VT of 3-4?ml/kg of IBW with the RR of 10-12 acts/min, and the PEEP of 5-8 cmH2O during CPB; the FiO2 is 80%. The primary endpoints are the incidence of the composite of PPCs and the PPCs score. The secondary endpoints refer to the incidence of the oxygenation index (PaO2/FiO2 ratio) <?300?mmHg at three time points (the moment arriving in the ICU, 6 and 12?h after arrival in the ICU), the surgical incision healing grade, the intubation time, the stay of ICU, the length of hospital stay, and mortality at 30?days after the surgery. DISCUSSION:The VONTCPB trial is the first study to assess the effects of strategies combining low tidal volume (VT) ventilation with different FiO2 during CPB on patients' outcomes. TRIAL REGISTRATION:ChiCTR1800015261 . Registered on 20 March 2018.

Project description:IntroductionCytokine storm and endotoxin release during cardiac surgery with cardiopulmonary bypass (CPB) have been related to vasoplegic shock and organ dysfunction. We hypothesised that early (during CPB) cytokine adsorption with oXiris membrane for patients at high risk of inflammatory syndrome following cardiac surgery may improve microcirculation, endothelial function and outcomes.Methods and analysisThe Oxicard trial is a prospective, monocentric trial, randomising 70 patients scheduled for cardiac surgery. The inclusion criterion is patients aged more than 18 years old undergoing elective cardiac surgery under CPB with an expected CPB time >90 min (double valve replacement or valve replacement plus coronary arterial bypass graft). Patients will be allocated to the intervention group (n=35) or the control group (n=35). In the intervention group, oXiris membrane will be used on the Prismaflex device (Baxter) at blood pump flow of 450 mL/min during cardiac surgery under CPB. In the control group, cardiac surgery under CPB will be conducted as usual without oXiris membrane. An intention-to-treat analysis will be performed. The primary endpoint will be the microcirculatory flow index measured by sublingual microcirculation device at day 1 following cardiac surgery. The secondary endpoints will be other microcirculation variables at CPB end, 6 hours after CPB, at day 1 and at day 2. We also aim to evaluate the occurrence of major cardiovascular and cerebral events (eg, myocardial infarction, stroke, ischaemic mesenteric, resuscitated cardiac arrest, acute kidney injury) within the first 30 days. Cumulative catecholamine use, intensive care unit length of stay, endothelium glycocalyx shedding parameters (syndecan-1, heparan-sulfate and hyaluronic acid), inflammatory cytokines (tumour necrosis factor (TNF) alpha, interleukin 1 (IL1) beta, IL 10, IL 6, lipopolysaccharide, endothelin) and endothelial permeability biomarkers (angiopoietin 1, angiopoietin 2, Tie2 soluble receptor and Vascular Endothelial Growth Factor (VEGF) will also be evaluated.Ethics and disseminationEthical approval has been obtained from the Institutional Review Board of the University Hospital of Amiens (registration number ID RDB: 2019-A02437-50 in February 2020). Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.Trial registration numberNCT04201119.

Project description:Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response, which is associated with postoperative morbidity and mortality. Hemoadsorption (HA) of cytokines may suppress inflammatory responses and improve outcomes. We tested a new sorbent used for HA (CytoSorb™; CytoSorbents Europe GmbH, Berlin, Germany) installed in the CPB circuit on changes of pro- and anti-inflammatory cytokines levels, inflammation markers, and differences in patients' perioperative course.In this first pilot trial, 37 blinded patients were undergoing elective CPB surgery at the Medical University of Vienna and were randomly assigned to HA (n = 19) or control group (n = 18). The primary outcome was differences of cytokine levels (IL-1?, IL-6, IL-18, TNF-?, and IL-10) within the first five postoperative days. We also analyzed whether we can observe any differences in ex vivo lipopolysaccharide (LPS)-induced TNF-? production, a reduction of high-mobility box group 1 (HMGB1), or other inflammatory markers. Additionally, measurements for fluid components, blood products, catecholamine treatment, bioelectrical impedance analysis (BIA), and 30-day mortality were analyzed.We did not find differences in our primary outcome immediately following the HA treatment, although we observed differences for IL-10 24 hours after CPB (HA: median 0.3, interquartile range (IQR) 0-4.5; control: not traceable, P = 0.0347) and 48 hours after CPB (median 0, IQR 0-1.2 versus not traceable, P = 0.0185). We did not find any differences for IL-6 between both groups, and other cytokines were rarely expressed. We found differences in pretreatment levels of HMGB1 (HA: median 0, IQR 0-28.1; control: median 48.6, IQR 12.7-597.3, P = 0.02083) but no significant changes to post-treatment levels. No differences in inflammatory markers, fluid administration, blood substitution, catecholamines, BIA, or 30-day mortality were found.We did not find any reduction of the pro-inflammatory response in our patients and therefore no changes in their perioperative course. However, IL-10 showed a longer-lasting anti-inflammatory effect. The clinical impact of prolonged IL-10 needs further evaluation. We also observed strong inter-individual differences in cytokine levels; therefore, patients with an exaggerated inflammatory response to CPB need to be identified. The implementation of HA during CPB was feasible.ClinicalTrials.gov: NCT01879176, registration date: June 7, 2013.

Dataset Information

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial.

Similar Datasets

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